Pozen Issued Patent Covering Aspirin Candidates

Pozen Issued Patent Covering Aspirin Candidates [the Herald-Sun, Durham, N.C.]

From Herald-Sun (Durham, NC) (June 27, 2012)

June 27--DURHAM -- Chapel Hill-based drug development company Pozen has been issued a patent that covers aspirin product candidates the company is developing to reduce stomach ulcers and other complications from taking aspirin alone.

The U.S. Patent and Trademark Office-issued patent was Pozen’s second covering claims for technology relating to the delivery of non-steroidal anti-inflammatory drugs, but was its first for claims focused on aspirin-based products, the company said in an announcement Tuesday.

The announcement followed less positive news from the company last week.

The company had announced June 20 that it had received a letter stating that the U.S. Food and Drug Administration made a preliminary finding that a Phase 1 study did not show that one of Pozen’s lead aspirin product candidates, PA32540, was bioequivalent to a reference drug, enteric-coated aspirin 325 mg.

The administration also said that an additional study would be needed for the development of a lower-dose aspirin product that the FDA had suggested the company apply for as part of its application for PA32540.

The FDA had suggested in a meeting in April that Pozen get approval for a lower-dose formulation containing 81 mg of aspirin as part of its application for PA32540, and had said that without that, it may limit the indication for PA32540.

In response to the FDA’s letter that Pozen announced June 20, the company said it planned to follow up with the FDA to determine next steps in meeting the bioequivalence requirements, and to determine any impact on the filing timeline for the company’s new drug application.

A spokeswoman for the company said in an e-mail Tuesday that the timing of the new drug application is not yet final, and that the company is "considering its options."

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Posted: June 2012


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